OKAY FACIAL WASH- salicylic acid gel 
Xtreme Tools International, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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OKAY Facial Wash- SALICYLIC ACID ACNE TREATMENT

Drug Facts

Active Ingredient

Salicylic Acid (2%)

Purpose

Acne Treatment

Use

For the treatment of acne.

Warning

For External use only

When using this product

■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ clean the skin thoroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Acrylates Crosspolymer-4, Sodium Hydroxide, Carica Papaya Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Panthenol, Fragrance

Questions or comments?
Call 1-305-622-7474 Mon-Fri 9 am-5 pm

PACKAGE LABEL

NDC 74553-015-01

Facial Wash

OKAY FACIAL WASH 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
Glycerin (UNII: PDC6A3C0OX)  
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PAPAYA (UNII: KU94FIY6JB)  
GUAVA (UNII: 74O70D6VG0)  
Panthenol (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74553-015-01118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/11/2023
Labeler - Xtreme Tools International, Inc (125398904)

Revised: 9/2023
Document Id: 001926ff-b22b-406c-aa75-a09f000a176d
Set id: 10a68aad-59d0-49ee-90db-995755971437
Version: 2
Effective Time: 20230911
 
Xtreme Tools International, Inc